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Trial record 1 of 1 for:    NCT04632966
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Safety Study of PTP-001 for Treating Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT04632966
Recruitment Status : Not yet recruiting
First Posted : November 17, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
Bioventus LLC

Brief Summary:
Evaluation of safety, tolerability, and efficacy of a single intra-articular (IA) injection of PTP-001, an allogeneic placental tissue particulate, in individuals with knee osteoarthritis (OA).

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: Biological: PTP-001 Phase 1

Detailed Description:
This open-label, dose-escalation study is expected to enroll 20 participants, 40-80 years of age and test two doses (low and high dose) of PTP-001, an allogeneic placental tissue particulate, in two unique cohorts of 10 participants each. Each participant will receive a single intra-articular (IA) injection of PTP-001. Following the completion of the first cohort in which 10 participants (Kellgren-Lawrence Grade 2 or 3 knee OA) will be treated with the low dose of PTP-001, safety data will be reviewed by an independent Data and Safety Monitoring Board (DSMB).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Open-label, dose-escalation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open-Label, Dose-Escalation Phase 1 Study of Intra-Articular Administration of an Allogeneic Human Placental Tissue Particulate (PTP-001) for the Treatment of Knee Osteoarthritis
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: PTP-001 - Low Dose (100 mg)
intra-articular injection of 100 mg PTP-001 resuspended with 4 mL of normal saline
Biological: Biological: PTP-001
allogeneic placental tissue particulate

Experimental: PTP-001 - High Dose (200 mg)
intra-articular injection of 200 mg PTP-001 resuspended with 4 mL of normal saline
Biological: Biological: PTP-001
allogeneic placental tissue particulate




Primary Outcome Measures :
  1. Incidence of local and systemic treatment emergent adverse events (AEs) and incidence of abnormal laboratory and immunogenicity panels [ Time Frame: Baseline to Week 52 ]
    Incidence of local and systemic treatment emergent adverse events (AEs), including clinical laboratory and immunogenicity panels, after a single intra-articular injection of PTP-001.


Secondary Outcome Measures :
  1. Western Ontario and McMaster University (WOMAC) Pain Responder Rate [ Time Frame: Week 26 and Week 52 ]
  2. WOMAC Physical Function Responder Rate [ Time Frame: Week 26 and Week 52 ]
  3. Change from baseline in pain of the index knee, by evaluating the WOMAC Pain subscale score (the possible total score ranging from 0-50 for pain) [ Time Frame: Baseline to Week 52 ]
    WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A (measure of pain) is measured on 11-point NRS ranging from 0 (none) to 10 (extreme), where higher score represents higher pain.

  4. Change from baseline in physical function of the index knee, by evaluating the WOMAC Physical Function subscale score (the possible total score ranging from 0-170 for Physical Function) [ Time Frame: Baseline to Week 52 ]
    WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC C (measure of physical function) is measured on 11-point NRS ranging from 0 (none) to 10 (extreme), where higher score represents higher pain.

  5. Change from baseline in patient global assessment of OA, by assessing the participants assessment of how they are doing considering arthritis in index knee (the possible answers include "Very Good", "Good", "Acceptable", "Poor", "Very Poor" [ Time Frame: Baseline to Week 52 ]
  6. Change from baseline in health-related quality of life, by assessing the items from the Short Form 36 (SF-36) survey [ Time Frame: Baseline to Week 52 ]
    The SF-36 measures 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health (the possible total normalized score ranges from 0-100). Higher scores on the SF-36 indicate better health status.


Other Outcome Measures:
  1. Change from baseline in biochemical markers (CTX-II & PRO-C2) [ Time Frame: Baseline to Week 52 ]
    • Urinary CTX-II samples
    • Serum PRO-C2 samples

  2. Change from baseline in joint space width of the index knee, assessed radiographically (OARSI radiographic scoring) [ Time Frame: Baseline to Week 52 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written consent to participate in the study
  • Male or female, aged 40 to 80 years
  • Symptomatic knee OA with Kellgren-Lawrence radiographic classification of 2 or 3
  • Non-responsive after at least 3 months of conservative therapy for knee OA
  • Females of childbearing potential must have negative pregnancy test result prior to treatment and must commit to highly effective methods of contraception for at least 6 months after treatment
  • Willingness to report oral analgesic treatment used for knee pain and to discontinue analgesic treatment for knee pain in 24 hours prior to each study visit
  • Willingness to limit use of pain rescue medication to oral acetaminophen for management of painful knee OA flare

Exclusion Criteria:

  • Body mass index (BMI) ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 with condition that warrants weight loss surgery
  • Presence of active infection of index knee or systemic infection requiring treatment within 3 months of Screening
  • Administration of IA injection within 3 months of Screening
  • Significant acute injury to index knee within 3 months of Screening
  • Surgery to index knee within 6 months of Screening or planned surgery to index knee within 6 months after Screening
  • Unstable index knee joint
  • History of radiation therapy of index knee
  • Known vascular or neurological disorder affecting the index knee
  • Osteonecrosis of either knee
  • Clinical diagnosis of inflammatory arthritis
  • Clinical diagnosis of autoimmune disease affecting the musculoskeletal system
  • Use of any other investigational therapy within 3 months of Screening or planned for the duration of the study
  • Current anti-coagulant use
  • History of receiving a solid organ or hematologic transplant
  • History of malignancy or radiotherapy within 5 years of Screening, except for basal or squamous cell carcinoma of the skin
  • Use of immunosuppressive or chemotherapeutic agents within 5 years of Screening
  • Known allergy to local anesthetics or allograft tissues
  • Known history of hepatitis
  • Known history of thrombotic or thromboembolic phenomena.
  • Known history of primary or secondary immunodeficiency disorders
  • Presence of concurrent medical condition that, in the investigator's judgement, could compromise participant safety or interfere with the required study assessments and study participation.

Note: Other protocol defined inclusion/exclusion criteria apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04632966


Contacts
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Contact: Drew Sullivan, BS 919-474-6703 drew.sullivan@bioventusglobal.com
Contact: MK Kottke, PhD mk.kottke@bioventusglobal.com

Locations
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United States, North Carolina
James R. Urbaniak, MD, Duke Sports Science Institute
Durham, North Carolina, United States, 27705
Contact: Emily K Reinke, PhD    919-684-8997    emily.reinke@duke.edu   
Sponsors and Collaborators
Bioventus LLC
Investigators
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Principal Investigator: Annunziato Amendola, MD James R. Urbaniak, MD, Duke Sports Science Institute
Publications:
Flannery CR, Seaman SA, Buddin KE, et al. Characterization and preclinical efficacy of PTP-001, a novel human tissue biologic in development for the treatment of OA. Osteoarthritis Cartilage. 2020 Apr;28(Supplement 1):S487-S489. doi: 10.1016/j.joca.2020.02.763

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Responsible Party: Bioventus LLC
ClinicalTrials.gov Identifier: NCT04632966    
Other Study ID Numbers: KOA-20-01
First Posted: November 17, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases